The top antitrust enforcers in the U.S. — the Department of Justice Antitrust Division (“DOJ”) and the Federal Trade Commission (“FTC”) — are tasked with preserving competition in the marketplace, including the market for health care products and services.  Competition benefits consumers through lower prices, increased availability of products and services, higher quality, and greater innovation.  The DOJ and FTC pursue their competition missions by investigating potentially anticompetitive conduct, reviewing mergers and acquisitions, and advocacy before states and other federal agencies.

Last week, DOJ and FTC commented on the potential competitive effects of telehealth related regulations proposed by Michigan and Delaware.  The DOJ commented on a bill working its way through the Michigan legislature that would expand the scope of health care authorized to be provided through telehealth services.  The FTC submitted comments on regulations proposed by the Delaware Board of Speech/Language Pathologists, Audiologists and Hearing Aid Dispensers that would permit these service to be provide via telehealth, but would require initial evaluations be done in person.

Michigan

A bill introduced in the Michigan legislature, SB 753, would broaden the services health care professionals can provide remotely using telecommunications technologies to include not only direct clinical services, but also health education and administration.  The bill would also permit health care professionals to obtain consent for treatment via telehealth directly or indirectly, and would permit prescribing drugs through telehealth if the health care provider is authorized to proscribe drugs in person and the prescribed drug is not a controlled substance.

The DOJ supported all three proposals as having “the potential to facilitate more robust use of telehealth services and expand health care competition by limiting or avoiding certain unnecessary barriers.”  Specifically, by lowering barriers such as health care access and cost, consumers may be more likely to seek out care sooner and obtain care faster through telehealth.  Expanding the services that can be provided via telehealth “may facilitate more diverse and innovative uses of telecommunications technologies to improve health care offerings beyond direct clinical services.”  By giving health care providers flexibility in how they obtain consent for treatment, without changing the underlying consent requirement, the bill would “help health professionals compete to improve access and provide health care services to patients.”  Finally, authorizing health care providers to prescribe certain drugs would make telehealth a more competitive option versus in-person visits.

Delaware

Delaware’s Board of Speech/Language Pathologists, Audiologists and Hearing Aid Dispensers proposed changes to their regulations that would allow licensed practitioners to deliver speech/language pathology, audiology, and hearing aid services remotely using telecommunications technologies — “telepractice” under the proposed regulation.  The proposed regulations would ensure that telepractice meets the in-person standard of care.  However, the initial evaluation could not be done by telepractice.

The FTC generally supported the authorization of telepractice to deliver these services because it would likely “increase[e] competition, consumer choice, and access to care.”  Its comments detailed the shortages of speech/language pathology and audiology services in certain parts of Delaware and research showing that these services can be effectively provided via telepractice.  The FTC encouraged the Board to reconsider the in-person initial evaluation requirement because it “may restrict entry of qualified telehealth practitioners, potentially decreasing competition, innovation, and health care quality, while increasing price.”  Instead, the FTC recommended that the Board allow licensed practitioners to use their professional judgment to determine whether an initial evaluation through telepractice is appropriate, consistent with the in-person standard of care and the patient’s health and safety, just as they can do for subsequent sessions.

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The agencies’ comments reveal a consistent approach to telehealth competition issues at the federal level.  Both agencies encouraged the states to reduce regulatory burdens on telehealth so that consumers can enjoy its potential benefits, including reduced health care costs and increased access to health care services.  Furthermore, in order to encourage the expansion of telehealth services, the agencies recommended that states narrowly tailor their regulations to directly address the regulation’s legitimate purposes, such as delivering the appropriate level of care and protecting patients’ health and safety.

The Food and Drug Administration (FDA) recently introduced a new webpage for reporting allegations of regulatory violations by medical device manufacturers or marketers. The new webpage, launched on October 21, 2016, enables any person—including current or former employees, competitors, or even plaintiffs’ attorneys—to submit a report to FDA regarding a broad variety of potential violations. Illustrating the types of allegations it expects to receive, FDA identifies:

  • non-FDA-approved promotion or advertising;
  • failing to submit required safety reports;
  • failing to comply with design or manufacturing responsibilities;
  • marketing a device without proper FDA clearance;
  • importing a device without satisfying the applicable legal requirements;
  • forging or falsifying an export certificate;
  • failing to register and list a device; and
  • knowingly deceiving FDA.

FDA encourages reporters “to include supporting information and contact information in case additional information is needed for FDA to understand the allegation and act on the report.” The agency also permits anonymous reporting and guarantees that it will maintain reporters’ anonymity unless legally required to do otherwise.

According to the new webpage, all reported allegations will be reviewed by the Center for Devices and Radiological Health (CDRH). CDRH is then charged with prioritizing its review based on the level of potential risks to patients. Following an assessment of the allegation, CDRH has the option of issuing a warning letter, conducting an inspection, or even requesting a recall. CDRH may also request additional information from or simply monitor the medical device manufacturer.

FDA implemented a similar reporting mechanism in 2010, the “Bad Ad Program,” which only addresses reports of potentially untruthful or misleading prescription drug advertising and promotion, rather than the broad array of violations addressed by the new website. Also, although anyone may submit a complaint to FDA, the Bad Ad Program “is focused primarily on health care professionals” and is “designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading.” Despite its comparatively limited scope, reports submitted through the Bad Ad Program led to the issuance of a number of enforcement letters. The new website is broader in scope and may have a similar, if not greater, impact. At any rate, whether or not this new website generates additional FDA actions against medical device manufacturers, records of inquiries and investigations completed by CDRH will potentially be available to plaintiffs’ attorneys through requests under the Freedom of Information Act.

The newly formed mHealth working group is tasked with developing guidelines for use in assessing the validity and reliability of data that is collected and processed by health and wellbeing apps. Ultimately, the guidelines will inform European Commission policy with respect to improving the safety and transparency of health information collected by mobile apps.

In April 2014, the European Commission published a Green Paper, which launched a public consultation on the challenges faced by the European mHealth market. The results of the public consultation were published in January 2015. Two open stakeholder meetings (held on 12 May 2015 and 6 July 2015) further emphasized the usefulness of a common mHealth methodological framework.

Continue Reading European Commission Forms mHealth Working Group

Welcome to your first edition of the Digital Health Download Blog. Our mission is to provide substantive cross-functional analysis of noteworthy digital health industry developments. For decades, Arnold & Porter LLP’s FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond to complex regulatory and compliance challenges. The convergence of software, digital, mobile and medical technologies is changing the way consumers and healthcare providers (HCPs) manage health and treat disease. These products and solutions provide greater flexibility, connectivity, and information to patients, providers and government and private payors. While they present numerous opportunities to revolutionize healthcare, these technologies also present a number of legal and regulatory challenges that encompass issues such as litigation, privacy and cybersecurity, telecommunications, mergers and acquisitions, intellectual property, healthcare compliance and corporate governance. We have a long tradition of leveraging the knowledge, experience and know-how of attorneys across various disciplines and practice areas to maximize efficiencies and provide practical advice and assistance to our clients. Our editorial team and contributors will strive to provide news, information and thought-provoking analysis that reflect our cross-functional approach and diverse perspectives.